NCT00006773

Brief Summary

Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2000

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

6.1 years

First QC Date

December 6, 2000

Last Update Submit

January 23, 2013

Conditions

Adult Anaplastic AstrocytomaAdult Anaplastic OligodendrogliomaAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of bortezomib defined as the dose level below that at which > 1 of 3-6 patients experience DLT

    Graded using the CTC version 2.0.

    3 weeks

Secondary Outcomes (2)

  • Biological effectiveness estimated using 20S proteosome activity

    Up to 6 years

  • Frequency of toxicity, graded using the CTC version 2.0

    Up to 6 years

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: bortezomib

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (bortezomib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed progressive or recurrent malignant glioma
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme
  • Prior low-grade gliomas that have progressed to high-grade after therapy allowed
  • Measurable disease by MRI or CT scan
  • Performance status - Karnofsky 60-100%
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 4 times upper limit of normal
  • Creatinine no greater than 1.7 mg/dL
  • Mini mental score at least 15
  • No concurrent serious infection or other medical illness that would preclude study participation
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Approaches to Brain Tumor Therapy Consortium

Baltimore, Maryland, 21231-1000, United States

Location

MeSH Terms

Conditions

AstrocytomaOligodendrogliomaGlioblastomaGliosarcomaBrain Neoplasms

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jeffrey Olson

    New Approaches to Brain Tumor Therapy Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2000

First Posted

January 27, 2003

Study Start

May 1, 2001

Primary Completion

June 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)